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OpenTrials
Completed

NCT Number: NCT01175200

Double the Dose of Clopidogrel or Switch to Prasugrel to Antagonize Proton Pump Inhibitor Interaction.

This study will establish the optimal therapeutic strategy for patients with a coronary artery disease (CAD) and chronically treated with clopidogrel 75 mg/day requiring co-administration of an anti-platelet treatment with P2Y12 antagonist and a PPI for treatment/prevention of GI ulceration.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Pitié Salpétrière Hospital

Paris, 75013, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • patient with stable Coronary Artery Disease (< 3 months) treated with clopidogrel (75mg/d)
  • Between 18 and 75 years of age
  • Body Mass Index between 18 and 30 kg/m2 and body weight not less than 60 kg
  • No major bleeding according to ISTH definition
  • Subjects who signed an informed consent document
  • Subjects who signed a separate pharmacogenomic informed consent document
  • Subjects registered to the French national welfare system

Exclusion criteria

  • Personal or family history of coagulation or bleeding disorders
  • Use of known inhibitors or inducers of CYP2C19 and CYP3A including grape fruit juice intake
  • Known hypersensitivity to lansoprazole, its excipients, or substituted benzimidazoles,
  • Known hypersensitivity to clopidogrel / prasugrel
  • Anti-platelet treatment other than clopidogrel + aspirin within 7 days before inclusion
  • Any formal indication to maintain PPI treatment
  • PPI within 15 days before inclusion in the study
  • Active pathology with 10 days before inclusion
  • Prior history of stent thrombosis
  • Prior history of Stroke
  • Employee of the investigator or study center, with direct involvement in the proposed study or other studies under the direction of that investigator or study center, as well as family members of the employees or the investigator.

Treatment and study plan

clopidogrel

Drug

antiplatelet agent

Prasugrel

Drug

antiplatelet agent

Lansoprazole

Drug

proton pum inhibitor

Other names: Lanzor, Ogast

Placebo

Drug

placebo comparator similar to lansoprazole

Primary outcomes

  1. Change in antiplatelet effect of clopidogrel

    Time frame: 14 days

    change in antiplatetelet effect of clopidogrel as compared to prasugrel when associated to lansoprazole (or placebo) in patients with stable angina

Secondary outcomes

  1. high on-treatment platelet reactivity Clopidogrel pharmacokinetics responses

    Time frame: 14 days

    compare persistant antiplatelet hyper reactivity in patients with stable angina and treated with clopidogrel or prasugrel associated with lansoprazole (or placebo)

Sponsors and collaborators

Lead sponsor

Ascopharm Groupe Novasco

Other

Collaborators

  • Groupe Hospitalier Pitie-Salpetriere
  • Medco Health Solutions, Inc.

Registry information

Official study title

Double the Dose of Clopidogrel or Switch to Prasugrel to Antagonize Proton Pump Inhibitor Interaction. A Prospective, Mono-center, Placebo- and Active Treatment-controlled, Randomized, Cross Over Study.

Acronym: DOSAPI

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Aug 4, 2010
Registry last updated
Jul 4, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.